Headgear and interface assembly using same

ABSTRACT

A headgear for attaching an object to a head of a user that is defined by a support beam and first and second ear loops coupled to opposite ends of the beam. The support beam generally wraps around a back of a user&#39;s neck or head and remains below the external occipital protuberance at all times during use of the headgear. This configuration minimizes the contact between the portions of the headgear and the user&#39;s hair. The first and second ear loops each include an upper arm adapted to be positioned above the ear, a lower arm adapted to be positioned below the ear, or both. An interface device is coupled to the headgear and held on the user&#39;s head by a tensioning force pulling the interface device toward the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) fromprovisional U.S. patent application No. 60/527,235 filed Dec. 5, 2003the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to a headgear adapted to supportan object on the head of a user, and, more particularly, to a headgearhaving a beam that spans the nape of a patient's neck or back of thehead for attaching an object to a patient while minimizing the amount ofstructure that overlies the user's hair, and to an interface assemblyand pressure support system that includes such a headgear.

2. Description of the Related Art

There are numerous situations where it is necessary to couple an objectto the face of a user. For example, non-invasive ventilation andpressure support therapies involve the placement of a patient interfacedevice, which is typically a nasal mask that covers the nose, anasal/oral mask that covers the nose and mouth, or full face mask thatcovers the patient face, on the face of a patient. The patient interfacedevice interfaces the ventilator or pressure support device with theairway of the patient, so that a flow of breathing gas can be deliveredfrom the pressure/flow generating device to the airway of the patient.Typically, non-invasive ventilation involves providing ventilatory gasto the airway of a patient without intubating the patient or surgicallyinserting a tracheal tube in their esophagus. Pressure support therapiesinvolve providing a pressure, such as a continuous positive airwaypressure (CPAP) or variable airway pressure, which varies with thepatient's respiratory cycle (bi-level pressure support) or with thecondition of the patient (auto-titrating pressure support), to treat amedical disorder, such as sleep apnea syndrome, in particular,obstructive sleep apnea (OSA), or congestive heart failure.

It is known to maintain such masks on the face of a wearer by a headgearhaving upper and lower straps, each having opposite ends threadedthrough connecting elements provided on the opposite sides and top of amask. Because such masks are typically worn for an extended period oftime, it is important the headgear maintain the mask in a tight enoughseal against a patient's face without discomfort.

One such headgear is disclosed in U.S. Pat. No. 5,517,986 (“the '986patent”), which is assigned to Respironics, Inc. of Pittsburgh, Pa., theassignee of the present application. The headgear taught by the '986patent includes a cap-like headpiece adapted to fit the crown and backof a patient's head. Lower straps provide a two-point connection with agas delivery mask. Straps depending from the headpiece are connected toand moveable relative to the lower straps. Additionally, a pair of upperstraps can be used to provide a four-point connection with the gasdelivery mask if needed.

Another such headgear also manufactured by Respironics, Inc. includesfive straps extending in a star-like manner from a rear joining piece,which is positionable along the rear portion of a patient's head. Thethree uppermost straps are adapted to fit on the patient's head. Acenter top strap extends from the joining piece across the top of thepatient's head to the patient's forehead. Upper side straps, which areprovided on either side of the top strap, extend from the joining piecealong the sides of a patient's head above the ears to attach to the topstrap at the patient's forehead. The top strap includes a pair ofelongated openings through which the upper side straps are threaded.

All of the straps in the headgear taught by the '986 patent include twocomponents of a hook and loop fastener, such as VELCRO®. The exterior ofthe straps include a loop fastener portion, and a hook fastener tabportion is attached to the end of each strap. When securing orfastening, the end of each the upper side strap is bent back on itselfto adhere the hook fastener tab portion to the exterior of the strapsincluding the loop fastener portion. More specifically, the hookfastener tab portion of the top strap is adapted to be threaded througha connecting element of the gas delivery mask and then bent back onitself to adhere the hook fastener tab portion to the exterior loopfastener portion.

Yet another headgear is disclosed in U.S. Pat. No. 5,724,965, which isalso assigned to Respironics, Inc. of Pittsburgh, Pa., the assignee ofthe present application. The headgear of U.S. Pat. No. 5,724,965includes a load bearing ear piece that encircles each ear of the user.Two head bands connect the ear pieces to one another. One headbandextends behind the head, and the other headband extends over the head.

These and other conventional headgear provide a convenient attachment ofthe patient interface device to the user's head. However, they sufferfrom several disadvantages. For example, conventional headgear strapscover significant portions of the user's head, including his or herhair. The present inventors recognized that some users prefer to avoidsignificant contact between their hair and the headgear. Contact betweenthe headgear straps and the user's hair, for example, can result inentanglement of the straps with the hair, making the headgear difficult,and perhaps painful to remove. Thus, some users prefer that the headgearstraps not cross over the hair. Therefore, a need exists for a headgearthat is easy to use and adjust, is comfortable, provides a stablesupport for the object being attached to the user, and does not restsignificantly on his or her hair.

In addition, some conventional headgear are perceived as bulky orcumbersome in that they cover a substantial area of the user's head.Furthermore, some users have an aversion to the relatively unattractiveappearance of conventional headgear, and may prefer headgear that lookless like a medical apparatus. Therefore, a need exists for a headgearthat does not cover much of the patient's head so that it is perceivedas being lightweight and slim and that appears less like a medicaldevice. Because conventional headgear are soft, floppy, and typicallyhave a myriad of flexible straps, the straps and other portions of themask can become entangled. Therefore, a further need exists for aheadgear that is easier to use in that it is less likely to becometangled in itself.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide aheadgear that overcomes the shortcomings of conventional headgear. Thisobject is achieved according to one embodiment of the present inventionby providing a headgear for attaching an object to a head of a user thatincludes a beam having a central portion, a first end portion, and asecond end portion. The beam provides all of the force needed to securesuch an object to a head of a user. The central portion wraps around aback of the neck or head and remains below the external occipitalprotuberance such that the first end portion is located proximate to theright side of the head and the second end portion is located proximateto the left side of the head. A first ear loop is coupled to the firstend portion of the beam, and a second ear loop is coupled to the secondend portion of the beam. The first ear loop includes a first upper armadapted to be positioned above an ear, a first lower arm adapted to bepositioned below the ear, or both. A second ear loop includes a secondupper arm adapted to be positioned above the ear, a second lower armadapted to be positioned below the user's ear, or both.

By providing a headgear that is disposed across the back of the head orneck, the headgear of the present invention avoids placing the strapsover much of the patient's hair. The use of a beam with ear loopsattached thereto that provide attachment points at both ears provides arelatively stable platform for supporting virtually any object on apatient's face. The present invention further provides a headgear thatis comfortable to the patient, fits a wide range of head sizes, andprovides improved aesthetics and usability.

It is yet another object of the present invention to provide aninterface assembly and a system for delivering a breathing gas to apatient that uses the headgear of the present invention.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are front, side, and rear perspective views of a firstembodiment of a headgear according to the principles of the presentinvention;

FIG. 2 is a side view of a patient wearing a first embodiment of aninterface assembly including a mask and the headgear of FIGS. 1A-1C;

FIG. 3 is a cross-sectional view of a portion of the headgear of FIGS.1A-1C taken along line 3-3 in FIG. 1A;

FIG. 4 is a rear perspective view of a second embodiment of a headgearaccording to the principles of the present invention;

FIGS. 5A and 5B are front and side perspective views of a thirdembodiment of a headgear according to the principles of the presentinvention;

FIG. 6 is a front perspective view of a fourth embodiment of a headgearaccording to the principles of the present invention;

FIG. 7 is a side view of a patient wearing a second embodiment of aninterface assembly including a patient monitoring device and theheadgear of FIGS. 1A-1C;

FIG. 8 is a side view of a patient wearing an interface assemblyincluding a fifth embodiment of the headgear of the present invention;

FIG. 9 is a side view of a patient wearing an interface assemblyincluding a sixth embodiment of the headgear of the present invention;and

FIG. 10 is a front perspective views of a seventh embodiment of aheadgear according to the principles of the present invention.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS OF THEINVENTION

FIGS. 1A-1C schematically illustrate an exemplary embodiment of aportion of a headgear 30 according to the principles of the presentinvention, and FIG. 2 illustrates a patient 32 wearing an interfaceassembly, generally indicated at 34, including a mask 36 and headgear30. Headgear 30 includes a beam 38, that is preferably rigid orsemi-rigid, having a central portion 40, a first end portion 42, and asecond end portion 44. Central portion 40 wraps around a back of auser's neck or head and remains below the user's external occipitalprotuberance, which is generally indicated at 45 and is typicallylocated at the back of the skull near the bottom where the head meetsthe neck. When properly positioned on the patient, as shown in FIG. 2for example, first end portion 42 of beam 38 is located proximate to theright side the patient's head and second end portion 44 is locatedproximate to the left side of the head. By providing a beam thatterminates behind the user's ear, the headgear distributes the holdingforce on the nape of the neck.

Beam 38 provides a first force, generally indicated by arrow A, thaturges the patient interface device 36 against the user's face. Firstforce A represents all of the force needed to secure an object, such asmask 36, on the head of the user, and counterbalances a second force, asgenerally indicated by arrow B, which represents the pulling force ofthe patient interface device on the user. At all times during use of theinterface assembly of the present invention, all portions of the beam 38that provide first force A, which resists or counterbalances secondforce B, remains below the user's external occipital protuberance, sothat no portions of the beam are above the user's external occipitalprotuberance during normal use of the headgear.

This configuration for the present invention provides two advantages.First, it allows the headgear to securely attach an object of the faceof the user without the need for a strap above the external occipitalprotuberance. This minimizes the area where the headgear overlaps theuser's hair. Second, this configuration allows forces A and B to beeffectively directed through the user's ear, without having any portionof the headgear overlie the ear, which tends to be quite uncomfortable.Directing the interface securing force through the user's ear providesthe most direct path for attaching an object on the face of the user.

Beam 38 can have a variety of shapes, sizes, and configurations so longas it provides the desired load supporting function and is comfortablefor the patient and remains below the user's external occipitalprotuberance at all times during use of the headgear. For example, inthe embodiment shown in FIGS. 1A-2, beam 38 is defined by a pair of beammembers 46 a and 46 b separated by a gap 48. Beam members 46 a and 46 bdefine lower upper and lower portions of the beam, respectively, andjoin one another at the first end portion and the second end portion ofthe beam. This multi-beam configuration is advantageous in that itdistributes the load supported by the beam over a relatively large areaat the nape of the neck. However, a single beam member configuration isalso contemplated by the present invention, as shown, for example, inFIGS. 5A and 5B. Of course, beam members in excess of two are alsocontemplated by the present invention.

The overall height of beam 38 is large enough to distribute the loadover an area that is large enough to provide a comfortable load on thepatient, yet small enough so as not to significantly impede the user'sability to articulate his or her head. The present invention alsocontemplates that the interior surface of beam 38, the overall shape ofthe beam, or a combination thereof can be contoured so as to moreclosely correspond to the surface of the patient or to correspond to theunderlying bone structure, thereby maximizing patient comfort.

A first ear loop 50 is coupled to first end portion 42 of beam 38, and asecond ear loop 52 is coupled to second end portion 44 of the beam. Thefirst and second ear loops are preferably joined to the beam in a fixedrelation, i.e., so that either ear loop does not move relative to theend portion of the beam to which it is attached. First ear loop 50includes a first upper arm 54 a that is positioned above an ear of auser when the headgear is properly located on the user, and a firstlower arm 54 b that is positioned below the user's ear. Similarly,second ear loop 52 includes a second upper arm 56 a that is positionedabove the ear of the user, and a second lower arm 56 b that ispositioned below the ear. The upper and lower arms on each ear loopprovide mountings to which headgear straps or other suitable connectingelements are attached for securing an object to be affixed to apatient's face to headgear 30.

First and second ear loops 50 and 52 can have a variety of shapes,sizes, and configurations. In a presently preferred exemplary embodimentof the invention, the first and second ear loops are semi-circular andare integrally formed with the beam so that the combination of the earloops and the beam define a unitary structure. The semi-circular orcrescent shape provides a stable support on the side of the head andprovides an area that is sized and shaped so as to receive the user'sear, as shown in FIG. 2. Upper and lower arms 54 a, 54 b, 56 a, and 56 bare also preferably integral with the first and second ear loops. Theoverall size of the ear loops and arms should be large enough to achievethe desired support and mounting functions, yet small enough to minimizethe area of contact on the user's head. The present invention alsocontemplates that the interior surface of first and second ear loops 50and 52 and upper and lower arms 54 a, 54 b, 56 a, and 56 b, the overallshape of these items, or a combination thereof can be contoured so as tomore closely correspond to the surface of the patient or to correspondto the underlying bone structure, thereby maximizing patient comfort.

Beam 38, first and second ear loops 50 and 52, and upper and lower arms54 a, 54 b, 56 a, and 56 b in this first exemplary embodiment arepreferably formed so that the overall structure is rigid or semi-rigid.For present purposes, “semi-rigid” means that these structures retaintheir shape when no load is applied on them, but flex to some degree toallow them to conform to the patient to reduce pressure points when aload is applied.

In an exemplary embodiment of the present invention, forming the beam,first and second ear loops, and upper and lower arms as a rigid orsemi-rigid structure is accomplished by forming one or more of thesestructures from a support member 58 that is rigid or semi-rigid andproviding a cushion member 60 disposed on a user contacting side of thesupport member. See FIG. 3. Examples of suitable rigid or semi-rigidmaterials suitable for use as support member 58 include metals(preferably a light-weight metal), plastics, or laminated fibers, or anycombination thereof, such as a plastic reinforced with metal supports.Examples of materials suitable for use as cushion member 60 include,foam, cloth, silicon, rubber, or any combination thereof. The presentinvention also contemplates that the rigid or semi-rigid nature of thebeam, first and second ear loops, and upper and lower arms can beaccomplished in any conventional manner, such as by providing stiffenedfabric. Stiffening the fabric can be accomplished, for example, byproviding a rigid or semi-rigid support or batten in the fabric and/orcoating, laminating, or otherwise reinforcing the fabric with astiffening agent, such as through screen printing process.

The support member and the cushion material are joined in anyconventional manner, such as by adhering the cushion to the supportmember. It is to be understood that the present invention contemplatesselectively attaching the support member and the cushion material sothat they can be detached from one another as needed. This is desirable,for example, for cleaning purposes. It also allows customization of theheadgear by allowing the user to mix and match the cushion material andthe support member. The present invention also contemplates that otherstructures can be provided on support member 58 and/or cushion member60. For example, a protective covering (not shown) can be provided oneither of these items.

An alternative embodiment of the present invention contemplates thatfirst and second ear loops 50 and 52 are formed as rigid or semi-rigidstructures and that beam 38 is not. This embodiment contemplates thatthe beam is a flexible member, such as piece of fabric material, thatsecures the first and second ear loops to one another. Dashed line 63 inFIGS. 1A-1C illustrate one possible point of delineation between therigid or semi-rigid first and second ear loops and the beam portion ofthe headgear, which can be rigid, semi-rigid, or completely flexible.

As noted above, upper and lower arms 54 a, 54 b, 56 a, and 56 b of firstand second ear loops 50 and 52 define a mounting member to whichadditional structures, such as straps, attach. These additionalstructures are needed to attach an object on a face of a user usingheadgear 30. In an exemplary embodiment of the present invention, theseadditional structures are flexible straps that connect to the object tobe attached on the patient. More specifically, the present inventioncontemplates providing a first upper strap portion 62 a coupled to firstupper arm 54 a and a first lower strap portion 62 b coupled to firstlower arm 54 b. Similar straps can be coupled to second upper and lowerarms 56 a and 56 b associated with second ear loop 52. The userinterface device to be attached to the user, such as the mask, headgear30, and the connecting straps define the interface assembly.

As shown in FIG. 2, straps 62 a and 62 b and the straps on the otherside of the headgear (not shown) connect to various locations on mask 36to hold the mask on the user's face. It can be appreciated that theconnecting straps can attach to the user interface device in any one ofan almost infinite number of configurations. Preferably, they arelocated so as to provide a secure attachment to the interface device anda stable support for this device on the user, while also maximizingpatient comfort, for example, by avoiding overlapping sensitive areassuch as the ears or eyes.

The straps connected to headgear 30 can be formed from a variety ofmaterials, or combination of materials, and can have a variety ofshapes, sizes, mechanical properties, and configurations. For example,the present invention contemplates that the straps are formed from asoft material (at least on the patient contacting side) and that thestraps are slightly flexible. The present invention also contemplatesthat the attachment point for the straps on the upper and/or lower armsand the attachment points on the interface device can be fixed oradjustable, and can be selectively detachable. For example, the strapscan be rotatably attached to headgear 30, the interface device (such asmask 36), or both. In addition, the straps can be connected to theheadgear, interface device, or both via a snap so that the straps can bedetached and reattached from headgear 30 or the interface device at theuser's convenience.

In an exemplary embodiment of the present invention, the interfaceassembly includes headgear 30, the straps, and an interface device thatcouples a gas delivery conduit 64, typically referred to as a patientcircuit, to an airway of the patient. Patient circuit 64 is typically aflexible tube that includes an attachment where it joins patientinterface device 36. It should be noted that patient interface device 36can be any conventional patient interface device, including a nasalmask, oral mask, nasal/oral mask, full face mask, nasal cannula, or anyother device that interfaces with an airway of a patient. Asschematically illustrated in FIG. 2, patient circuit 64 communicates aflow of gas from a gas flow generating device 66, such as a conventionalpressure support system or ventilator, so that gas is delivered from thegas flow generator to the airway of the patient.

Gas flow generating device 66 can be any conventional device thataccomplishes this function, such as a CPAP device, bi-level device,auto-titrating device, or any other pressure support system orventilator using any conventional mode of therapy delivery. Althoughpatient circuit 64 is illustrated in FIG. 2 as being a single limbcircuit, the present invention contemplates that the patient circuit caninclude multiple limbs and can include other elements, such as filters,exhaust ports, flow control valve, pressure relief valves, humidifiers,and sensors.

FIG. 4 illustrates a headgear 68 according to a second embodiment of thepresent invention. Headgear 68 is similar to headgear 30 in manyrespects. However, headgear 68 illustrates several optional featuresthat are believed to make the headgear easier to use and morecomfortable for a wider variety differently sized and shaped patients.

For example, headgear 68 includes a first ear loop 70 and a second earloop 72 that are rotatably coupled to first end portion 42′ and secondend portion 44′, respectively, of beam 38′. This rotatable attachmentcan be provided in any one of a variety of techniques. In theillustrated exemplary embodiment, an axis 74 is provided on each endportion of the beam about which the ear loop rotates, as indicated, forexample, by arrow C. Other techniques for allowing the ear loop to moverelative to the beam include a sliding channel configuration, where theear loop slides along a path relative to the beam by providing, forexample, a tongue and groove or slot and pin, configuration that allowsthe ear loop to move relative to the beam, yet remain attached thereto.By allowing the ear loops to rotate relative to the beam, the headgearis able to self-align to a proper position on the patient so that oneheadgear size or style will fit a larger number of patients with thesame degree of comfort that would otherwise require multiple headgearchoices.

Another feature of headgear 68 is the ability to adjust the distancebetween first ear loop 70 and second ear loop 72 along a length of beam38′. That is an adjusting mechanism associated with the first ear loop,the second ear loop or both is provided so that the first or second earloops can be moved along the beam, as indicated, for example, by arrow Din FIG. 4. In this illustrated exemplary embodiment, this transverseadjustability made possible by providing an alternative axis 76 ormounting member to which the ear loop can selectively attach. To adjustthe ear loops in the transverse direction (corresponding to arrow D)thereby effectively changing the length of beam 38, the first and/orsecond ear loop is detached from one axis and reattached to the otheraxis. This configuration provides flexibility in the size andconfiguration for the headgear.

FIGS. 5A and 5B illustrate a headgear 78 that includes yet anothertechnique for adjusting the distance between a first ear loop 80 and asecond ear loop 82. In this embodiment, headgear 78 includes a beam,generally indicated at 84, that has a length adjusting capability ratherthan adjusting the attachment location for the ear loops. Of course, thepresent invention contemplates providing the beam length adjustmentcapability in combination with the ear loop position adjustmentcapability. Other than providing a length adjustment capability, beam 84corresponds to beam 38, 38′ from the previous embodiments.

Adjusting the length of beam 84 is made possible, according to oneexemplary embodiment of the present invention, by separating beam 84into a first beam member 86 and a second beam member 88 that areselectively connectable to one another at a number of differentoverlapping positions. That is, the first beam member and the secondbeam member are connectable such that the degree of overlap of these twomembers can be changed, thereby effectively changing the length of thebeam. In this embodiment, a plurality of engaging portions orprotrusions are provided on one beam member and a plurality of receivingportions are provided on the other beam member. The length of the beamis controlled based on the selection of which engaging portions arecoupled to associated receiving portions. It is to be understood thatthis specific implementation represents only one of a variety oftechniques that can be used to change the amount of overlap between thetwo beam members.

FIG. 6 is a front perspective view of a fourth embodiment of a headgear90 according to the principles of the present invention. This embodimentis similar to the previous embodiments except that upper and lower arms54 a′ and 54 b′ of first ear loop 50′ and upper and lower arms 56 a′ and56 b′ of second ear loop 52′ are adjustable. That is, the distancebetween upper arms 54 a′, 56 a′ and lower arms 54 b′ and 56 b′associated with each ear loop can be changed, as indicated by arrow E.This feature of the present invention allows the headgear to becustomized to the physical dimensions of the patient.

In the illustrated exemplary embodiment, an adjusting mechanism 92 thatallows the distance between the upper arms and the lower arms to bechanged is similar to that discussed above with respect to FIGS. 5A and5B. For example, in this embodiment, engaging portions or protrusionsare provided on upper arms 54 a′, 56 a′ and corresponding receivingportions are provided on lower arms 54 b′ and 56 b′, or vice versa. Itto be understood, however, that the present invention contemplates thatany technique that allows the distance between the upper arms and thelower arms to be changed can be used.

FIG. 7 is a side view of a patient 32 wearing a second embodiment of aninterface assembly 94 according to the principles of the presentinvention. In this embodiment, interface assembly includes headgear 30described above with respect to FIGS. 1A-1C. However, the interfacedevice for use with headgear 30 is not a nasal mask. Instead, theinterface device is a patient monitoring device 96 that is attached tothe face of the patient so as to monitor a parameter of the patient,such as patient airflow.

It is to be understood that the number, type, size, function, and othercharacteristics of the objects that can be used as the patient interfacedevice that are suitable for use with a headgear of the presentinvention are nearly limitless. For example, the present inventioncontemplates that the headgear of the present invention can be used toattach other medical devices to the patient, such as a spirometer orother monitor, to the patient. On the other hand, the headgear can alsobe used to attach non-medical devices to the face of the user, such asgas masks, cosmetic objects, electronic devices, or apparel. No attemptis made in this disclosure to list the different types of objects thatcan serve as interface devices that can be held on the head of thepatient by the headgear of the present invention. The monitoring deviceand headgear arrangement shown in FIG. 6 are provided merely as anexample of other configurations for the interface device that aresuitable for use therewith.

FIG. 8 illustrates a fifth embodiment of a headgear 100 according to theprinciples of the present invention. In this embodiment, headgear 100includes a beam 102 and first and second ear loops 104 (only one ofwhich is shown). The nature, structure, and possible configurations forthe beam and the ear loops in this embodiment and the interconnectionbetween these members corresponds to that discussed above. For example,an exemplary embodiment of the present invention contemplates formingthe ear loops as a rigid or semi-rigid structure and the beam as arigid, semi-rigid, or flexible structure attached in a fixed relation tothe ear loops. In this embodiment, the ear loop includes only a lowerarm 106, so that no structure is located above the user's ear. Straps108 attach the object to be held on the patient's face, such as a mask110, to the ear loop portions of headgear 100.

FIG. 9 illustrates a sixth embodiment of a headgear 112 according to theprinciples of the present invention. In this embodiment, headgear 112includes a beam 114 and first and second ear loops 116 (only one ofwhich is shown). Again, the nature, structure, and possibleconfigurations for the beam and the ear loops in this embodiment and theinterconnection between these members corresponds to that discussedabove. For example, an exemplary embodiment of the present inventioncontemplates forming the ear loops as a rigid or semi-rigid structureand the beam as a rigid, semi-rigid, or flexible structure attached in afixed relation to the ear loops. In this embodiment, the ear loopincludes only an upper arm 118, so that no structure is located abovethe user's ear. Straps 108 attach the object to be held on the patient'sface, such as a mask 110, to the ear loop portions of headgear 112.

FIG. 10 is a side perspective view of a further embodiment of patientinterface assembly 120 according to the principles of the presentinvention. The patient interface assembly includes a headgear 122, anobject 124 to be attached to the user's face (which in this exemplaryembodiment is a mask), and an attaching mechanism 126 for attachingobject 124 to headgear 122. One of the unique aspects of this embodimentresides in this attaching mechanism. While FIG. 10 shows the attachingmechanism associated with one side of the headgear, it is to beunderstood that a similar attaching mechanism can be provided on theother side of the headgear.

Attaching mechanism 126 includes a single length of fastening material,such as a cord or strap, that is fed back and forth between headgear 122and mask 124 through fastening elements on the mask and headgear. Morespecifically, in the illustrated exemplary embodiment, a first portion128 of the fastening material is fixed to upper arm 130 and extends to afirst portion of mask 124 where it is looped through a first fasteningelement 132 on the mask so that a second portion 134 extends back to theheadgear. A third portion 136 of the fastening material is threadedthrough one or more guides 138 so that a fourth portion 140 extends froma lower arm 141 to the mask, is looped through a second fasteningelement 142 on the mask, and provides an attaching portion 144 thatextends back to the headgear.

The fastening material is allowed to slide in first fastening element132, guides 138, and second fastening element 142 so that increasing thetension on attaching portion 144 increases the tension on the mask atthe first and the second fastening elements. This configuration allowsthe tension between the mask and the headgear to be effectively adjustedat two locations, i.e., the upper and lower arms, by pulling on oneelement, namely attaching portion 144. Once the desired tension isachieved, an attaching element 146 provided on attaching portion issecured to the headgear. For example, the present invention contemplatesattaching portion 144 to headgear 120 by means of a hook and loopattachment device, where one element is provided on attaching element146 and the other element is provided on beam 148. Of course, anyconventional fastening technique can be used to secure the attachingportion of the attaching mechanism to the headgear.

It should be further understood that the present invention contemplatesthat the winding pattern by which the fastening material is attached toand between the headgear and the object to be attached to the patientcan have a variety of different configurations. For example, more runsback and forth between the headgear and mask can be provided. Thefastening material can cross between the sides of the patient interfaceassembly. The attaching portion can be attached to the mask. A singlefastening material running between the sides of the mask can beprovided, so that the user need only apply tension on one attachingportion to adjust the tension at multiple locations on the mask. Thepresent invention contemplates, for example, eliminating first portion128 of attaching element 146 so that the end of the attaching element isconnected to the patient interface device rather than the headgear, asshown in FIG. 10. Thus, the first run for the attaching elements isattaching portion 134 running from the mask to the headgear.

It can be appreciated from the foregoing description that the presentinvention contemplates other shapes, sizes, and configurations for theinterface assembly and, in particular, for the headgear and interfacedevice defining the interface assembly. In addition, the straps or otherconnecting elements that are used to couple the headgear and interfacedevice are also subject to variations. For example, straps need not beattached to both the upper and lower arms, but can be provided on eitherthe upper arm or the lower arm depending on the specific arrangementneeded to properly position the interface device on the head of theuser.

By providing a headgear that is disposed across the back of the head orneck, the headgear of the present invention avoids placing the strapsover much of the patient head and hair. The use of a beam with ear loopsattached thereto that provide attachment points at both ears provides arelatively stable platform for supporting virtually any object on apatient's face. In addition, because the headgear does not cover much ofthe patient's head, it is perceived as being lightweight and slim andthat appears less like a medical device, i.e., more aestheticallypleasing. In addition the use of the beam with ear loops provides aheadgear that is less likely to become tangled in itself.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood that,to the extent possible, the present invention contemplates that one ormore features of any embodiment of the present invention can be combinedwith the features of any other embodiment.

1. A headgear for attaching an object to a head of a user comprising: abeam having a central portion, a first end portion, and a second endportion, wherein the central portion wraps around a back of a user'sneck or head and remains below such a user's external occipitalprotuberance such that the first end portion is located proximate to aright side of such a user's head and the second end portion is locatedproximate to a left side of such a user's head, and wherein the beam isrigid or semi-rigid; a first ear loop operatively coupled to the firstend portion of the beam, wherein the first ear loop is rigid orsemi-rigid and is generally “C” shaped, wherein the first ear loopincludes a first upper arm adapted to be positioned above an ear of sucha user and a first lower arm adapted to be positioned below an ear ofsuch a user, and wherein a first gap is defined between the first upperarm and the first lower arm such that the first ear loop is not disposedover a front of such a user's ear responsive to the headgear beingdonned by a user; a second ear loop operatively coupled to the secondend portion of the beam, wherein the second ear loop is rigid orsemi-rigid and is generally “C” shaped, wherein the second ear loopincludes a second upper arm adapted to be positioned above an ear ofsuch a user and a second lower arm adapted to be positioned below an earof such a user, and wherein a second gap is defined between the secondupper arm and the second lower arm such that the second ear loop is notdisposed over a front of such a user's ear responsive to the headgearbeing donned by a user; a first strap operatively coupled to the firstupper arm or the first lower arm of the first ear loop; and a secondstrap operatively coupled to the second upper arm or the second lowerarm of the second ear loop, and wherein the headgear does not include astrap disposed over a top of such a user's head when the headgear isdonned by a user.
 2. The headgear of claim 1, wherein the first ear loopand the second ear loop are rotatably coupled to the beam.
 3. Theheadgear of claim 1, wherein the beam includes an upper portion and alower portion, and wherein the upper portion and the lower portion arejoined at the first end portion and the second end portion and separatedat the central portion.
 4. The headgear of claim 1, wherein the firstear loop and the second ear loop are integral with the beam.
 5. Theheadgear of claim 1, further comprising an adjusting mechanismassociated with the beam adapted to adjust to adjust a distance betweenthe first end portion and the second end portion.
 6. The headgear ofclaim 1, further comprising an adjusting mechanism associated with atleast one of the first ear loop and the second ear loop adapted toadjust a distance between the first ear loop and the second ear loopalong a length of the beam.
 7. The headgear of claim 1, wherein thefirst ear loop includes both the first upper arm and the first lowerarm, and wherein the second ear loop includes both the second upper armand the second lower arm.
 8. The headgear of claim 1, wherein at least aportion of the beam, the first ear loop, the second ear loop, or anycombination thereof comprises a cushioning member disposed on a rigid orsemi-rigid support member.
 9. The headgear of claim 7, wherein the firststrap is coupled to the first upper arm and the second strap is coupledto the second upper arm, and further comprising: a third strapoperatively coupled to the first lower arm; and a fourth strapoperatively coupled to the second lower arm.
 10. The headgear of claim1, wherein the central portion has a curvature substantiallycorresponding to a curvature of a nape of human neck.
 11. An interfaceassembly comprising: a) a user interface device adapted to contact aportion of a face of a user; and b) a headgear comprising: 1) a beamhaving a central portion, a first end portion, and a second end portion,wherein the central portion wraps around such a user's neck or head andremains below such a user's external occipital protuberance such thatthe first end portion is located proximate to a right side of such auser's head and the second end portion is located proximate to a leftside of such a user's head, and wherein the beam is rigid or semi-rigid,2) a first ear loop operatively coupled to the first end portion of thebeam, wherein the first ear loop is rigid or semi-rigid and is generally“C” shaped, wherein the first ear loop includes a first upper armadapted to be positioned above an ear of such a user and a first lowerarm adapted to be positioned below an ear of such a user, and wherein afirst gap is defined between the first upper arm and the first lower armsuch that the first ear loop is not disposed over a front of such auser's ear responsive to the headgear being donned by a user, 3) asecond ear loop operatively coupled to the second end portion of thebeam, wherein the second ear loop is rigid or semi-rigid and isgenerally “C” shaped, wherein the second ear loop includes a secondupper arm adapted to be positioned above an ear of such a user and asecond lower arm adapted to be positioned below an ear of such a user,and wherein a second gap is defined between the second upper arm and thesecond lower arm such that the second ear loop is not disposed over afront of such a user's ear responsive to the headgear being donned by auser, 4) a first strap operatively coupling the first ear loop to afirst portion of the user interface device, and 5) a second strapoperatively coupling the second ear loop to a second portion of the userinterface device, and wherein the headgear does not include a strapdisposed over a top of such a user's head when the headgear is donned bya user.
 12. The interface assembly of claim 11, wherein the first earloop and the second ear loop rotatably coupled to the beam.
 13. Theinterface assembly of claim 11, wherein the beam includes an upperportion and a lower portion, and wherein the upper portion and the lowerportion are joined at the first end portion and the second end portionand separated at the central portion.
 14. The interface assembly ofclaim 11, wherein the first ear loop and the second ear loop areintegral with the beam.
 15. The interface assembly of claim 11, furthercomprising an adjusting mechanism associated with the beam adapted toadjust a distance between the first end portion and the second endportion
 16. The interface assembly of claim 11, further comprising anadjusting mechanism associated with at least one of the first ear loopand the second ear loop adapted to adjust a distance between the firstear loop and the second ear loop along a length of the beam.
 17. Theinterface assembly of claim 11, wherein the first ear loop includes boththe first upper arm and the first lower arm, and wherein the second earloop includes both the second upper arm and the second lower arm. 18.The interface assembly of claim 11, wherein at least a portion of thebeam, the first ear loop, the second ear loop, or any combinationthereof comprises a cushioning member disposed on a rigid or semi-rigidsupport member.
 19. The interface assembly of claim 17, wherein thefirst strap is operatively coupled to the first upper arm, and thesecond strap is operatively coupled to the second upper arm, and furthercomprising: a third strap operatively coupled to the first lower arm;and a fourth strap operatively coupled to the second upper arm.
 20. Theinterface assembly of claim 11, wherein the central portion has acurvature substantially corresponding to a curvature of a nape of humanneck.
 21. The interface assembly of claim 11, wherein the user interfacedevice is a nasal mask, a nasal/oral mask, a full face mask, arespiratory monitor, or any combination thereof.
 22. A system fordelivering a breathing gas to a patient comprising: a) a gas flowgenerating device that produces a flow of gas; b) a conduit having afirst end portion operatively coupled to the gas flow generating deviceand a second end portion, wherein the conduit carries the flow of gasfrom the gas flow generating device during operation of the system; c) auser interface device coupled to the second end portion of the conduit;and d) a headgear comprising: 1) a beam having a central portion, afirst end portion, and a second end portion, wherein the central portionwraps around such a user's neck and remains below such a user's externaloccipital protuberance such that the first end portion is locatedproximate to a right side of such a user's head and the second endportion is located proximate to a left side of such a user's head, andwherein the beam is rigid or semi-rigid, 2) a first ear loop operativelycoupled to the first end portion of the beam, wherein the first ear loopis rigid or semi-rigid and is generally “C” shaped, wherein the firstear loop includes a first upper arm adapted to be positioned above anear of such a user and a first lower arm adapted to be positioned belowan ear of such a user, and wherein a first gap is defined between thefirst upper arm and the first lower arm such that the first ear loop isnot disposed over a front of such a user's ear responsive to theheadgear being donned by a user, 3) a second ear loop operativelycoupled to the second end portion of the beam, wherein the second earloop is rigid or semi-rigid and is generally “C” shaped, wherein thesecond ear loop includes a second upper arm adapted to be positionedabove an ear of such a user and a second lower arm adapted to bepositioned below an ear of such a user, and wherein a second gap isdefined between the second upper arm and the second lower arm such thatthe second ear loop is not disposed over a front of such a user's earresponsive to the headgear being donned by a user, 4) a first strapoperatively coupling the first ear loop to a first portion of the userinterface device, and 5) a second strap operatively coupling the secondear loop to a second portion of the user interface device, and whereinthe headgear does not include a strap disposed over a top of such auser's head when the headgear is donned by a user.
 23. The system ofclaim 22, wherein the first ear loop and the second ear loop arerotatably coupled to the beam.
 24. The system of claim 22, wherein thebeam includes an upper portion and a lower portion, and wherein theupper portion and the lower portion are joined at the first end portionand the second end portion and separated at the central portion.
 25. Thesystem of claim 22, wherein the first ear loop and the second ear loopare integral with the beam.
 26. The system of claim 22, furthercomprising an adjusting mechanism associated with the beam adapted toadjust a distance between the first end portion and the second endportion.
 27. The system of claim 22, further comprising an adjustingmechanism associated with at least one of the first ear loop and thesecond ear loop adapted to adjust a distance between the first ear loopand the second ear loop along a length of the beam.
 28. The system ofclaim 22, wherein the first ear loop includes both the first upper armand the first lower arm, and wherein the second ear loop includes boththe second upper arm and the second lower arm.
 29. The system of claim22, wherein at least a portion of the beam, the first ear loop, thesecond ear loop, or any combination thereof comprises a cushioningmember disposed on a rigid or semi-rigid support member.
 30. The systemof claim 28, wherein the first strap is operatively coupled to the firstupper arm, and the second strap is operatively coupled to the secondupper arm, and further comprising: a third strap operatively coupled tothe first lower arm; and a fourth strap operatively coupled to thesecond upper arm.
 31. The system of claim 22, wherein the centralportion has a curvature substantially corresponding to a curvature of anape of human neck.
 32. The system of claim 22, wherein the userinterface device is a nasal mask, a nasal/oral mask, a full face mask, arespiratory monitor, or any combination thereof.